About clinical trials
Clinical trials are scientific research studies that explore whether a potential drug (often called an investigational drug) is safe and effective for people. They are designed to help us find:
- Potential new treatments
- Potential new versions of existing treatments
- Potential new uses for existing treatments
We are looking for people with schizophrenia to take part in the TALLY clinical trial, which is researching treatments for cognitive impairment associated with schizophrenia (CIAS).
Clinical trials are important because they may help us discover more about diseases, how to potentially treat them and ways to keep people healthy. Without clinical trials and the volunteers who take part, it would be almost impossible to develop any potential new medications.
What are clinical trials?
- Clinical trials help us learn more about an investigational drug, but only after it has gone through extensive testing in a lab
- All drugs must be tested in clinical trials before they can be approved and made available for use
- Without people like you willing to volunteer, it would not be possible to develop potential medicines
If you or someone you care about has CIAS, find out if the trial is happening near you and contact the study team.
What is a placebo in clinical trials?
In some clinical trials, a placebo is given to a group of people instead of the active (real) investigational drug.
A placebo looks exactly like the investigational drug but does not contain any active ingredients. This helps scientists know if any changes in your health are due to the investigational drug and not something else. In the TALLY clinical trial, both the placebo and investigational drug are a capsule you would swallow.
Often, neither participants nor their study team know whether they are taking the investigational drug or the placebo.
How are clinical trials set up?
In Phase 1 clinical trials the investigational drug is tested in people and usually involves a small group of healthy volunteers.
Phase 2 trials test how safe and potentially effective an investigational drug may be for people with the condition the investigational drug hopes to impact. This phase often compares the investigational drug to a placebo.
TALLY is a Phase 2 clinical trial for people with schizophrenia.
If Phase 2 shows that the investigational drug works the way scientists hope it will, it moves to Phase 3. Phase 3 trials test the investigational drug in an even larger number of people to study its effectiveness, side effects and safety. This phase also often compares the investigational drug to a placebo.
Why take part in a clinical trial?
- You may receive the investigational drug or the placebo
- Your health may be monitored more closely while you are on the study than it would normally
- You may provide valuable information that might help grow our medical knowledge
Always remember that taking part is completely voluntary. If you join the study but then change your mind, you can leave at any time for any reason.
All known side effects are described in the informed consent form, which you must read and sign before taking part. However, unexpected reactions are always a possibility.
There is no guarantee your condition will be impacted if you receive the investigational drug and there may be no benefit from participating in a clinical study.
By taking part you could be helping provide future schizophrenia patients with potential new treatment options.